BTI: A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01345591
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Injuries resulting in facial trauma are common, and can have devastating consequences on your quality of life. While the facial bones can often be reconstructed, physicians strive to find better ways to accurately restore injured facial features.

In this clinical trial funded by the Department of Defense, the investigators are evaluating how effectively fat grafting can restore facial features, and how the filling effect of the fat graft lasts over time in participants with visible facial injuries. All procedures for this research study will be performed at the University of Pittsburgh Medical Center.

Condition or Disease	Intervention/Treatment	Phase
Facial Injuries; Adipose Tissue	Procedure: Fat Grafting	N/A

Detailed Description

The purpose of this research is to evaluate how well the filling effect of the fat remains over time. A person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. This is called fat grafting, and it is a common procedure, performed approximately 65,000 times by plastic surgeons in the United State last year. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth defects, or other causes. Typically, the transferred fat results in an increase in volume of the body site being treated.

Fat grafting is a minimally invasive surgical procedure in which a person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost shape or fullness due to injury. This procedure is performed through very small incisions that allow a hollow tube to pass through.

Fat grafting is a common cosmetic and reconstructive procedure. It was performed approximately 65,000 times by plastic surgeons in the United States last year. Typically, the transferred fat results in an increase in volume and shape of the body site being treated. The investigators believe this clinical technique of fat grafting could be of significant benefit to patients with facial injuries. The fat grafting procedure being performed in this trial is considered to be research, but not an experimental procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Structural Fat Grafting for Craniofacial Trauma
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fat Grafting Twenty (20) subjects who have had severe facial trauma, 18 years of age and older enrolled to clinical trial will receive Fat grafting intervention procedure	Procedure: Fat Grafting

Outcome Measures

Primary Outcome Measures

1. Volume [3 months and 9 months post op.]

   fat graft volume

Secondary Outcome Measures

1. SWAP, COPE and CSQ-8 [as assessed at baseline, 7-21 days, 3 months and 9 months post op.]

   three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Aged 18 years or older and able to provide informed consent

2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate

3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved

4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses

5. The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection that in a manner that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat an uninjured contralateral region with lipoaspirate in order to obtain symmetry.

6. Willing and able to comply with follow up examinations, including radiographic studies

Exclusion Criteria:

1. Age less than 18 years

2. Inability to provide informed consent

3. Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating).

4. Active infection anywhere in the body

5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment

6. Known coagulopathy

7. Pregnancy -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• United States Department of Defense

Investigators

• Principal Investigator: Joseph P Rubin, MD, Associate Professor of Plastic Surgery at the University of Pittsburgh, Faculty appointment-McGowan Institute of Regenerative Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Burnouf M, Buffet M, Schwarzinger M, Roman P, Bui P, Prévot M, Deleuze J, Morini JP, Franck N, Gorin I, Dupin N. Evaluation of Coleman lipostructure for treatment of facial lipoatrophy in patients with human immunodeficiency virus and parameters associated with the efficiency of this technique. Arch Dermatol. 2005 Oct;141(10):1220-4.
• Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S.
• Kaufman MR, Bradley JP, Dickinson B, Heller JB, Wasson K, O'Hara C, Huang C, Gabbay J, Ghadjar K, Miller TA. Autologous fat transfer national consensus survey: trends in techniques for harvest, preparation, and application, and perception of short- and long-term results. Plast Reconstr Surg. 2007 Jan;119(1):323-331. doi: 10.1097/01.prs.0000244903.51440.8c.

• Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01345591
• Other Study ID Numbers: PRO09060101
• First Posted: May 2, 2011
• Last Update Posted: Jul 11, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh: BTI; Craniomaxillofacial (CMF) Battle-injured (BI); Facial Trauma; Fat Grafts; Autogenous Fat Transfers (AFT); Wounded warriors
• Additional relevant MeSH terms: Facial Injuries; Facies

Study Results

Participant Flow

Arm/Group Title	Fat Grafting
Arm/Group Description	fat grafting for facial trauma
Period Title: Overall Study
STARTED	20
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Fat Grafting
Arm/Group Description	Fat Grafting for facial trauma
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
volume (milliliters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milliliters]	1.0 (0.0001)
tissue thickness (milliliters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milliliters]	0.352 (0.180)

Outcome Measures

1. Primary Outcome

Title	Volume
Description	fat graft volume
Time Frame	3 months and 9 months post op.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fat Graft Volume at 3 Months	Fat Graft Volume at 9 Months
Arm/Group Description	fat grafting for facial trauma, volume measured at 3 months post-op	fat grafting for facial trauma, volume measured at 9 months post-op
Measure Participants	19	19
Mean (Standard Deviation) [milliliters]	0.576 (0.188)	0.621 (0.191)

2. Secondary Outcome

Title	SWAP, COPE and CSQ-8
Description	three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.
Time Frame	as assessed at baseline, 7-21 days, 3 months and 9 months post op.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fat Grafting_evaluation at Baseline	Fat Grafting_7-21 Days Post op	Fat Grafting_3 Months Post op	Fat Grafting_9 Months Post-op
Arm/Group Description	quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires	quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires	quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires	quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
Measure Participants	20	20	20	20
SWAP	59.7 (11.1)	57.8 (7.0)	57.9 (8.3)	56.3 (6.3)
COPE	57.1 (8.5)	56.8 (13.1)	54.4 (13.5)	55.1 (7.7)
CSQ-8	27.0 (2.9)	30.9 (2.4)	31.3 (2.2)	30.7 (2.4)

Adverse Events

Arm/Group Title	Fat Grafting
Arm/Group Description	fat grafting for facial trauma
All Cause Mortality
	Fat Grafting
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fat Grafting
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Fat Grafting
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Surgical and medical procedures
bruising	20/20 (100%)
swelling at injection site	20/20 (100%)
redness at injection site	20/20 (100%)
Vascular disorders
warmth	20/20 (100%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.